Polymer Laminates for MicrofluidicLife Science and IV Diagnostics Applications
Leanna M. Levine, Ph.D. Founder , ALine, Inc.
About ALine
Founded in 2003 Revenue from of Product Sales and Custom Services
Currently 6 employees Sales through distribution (Ocean Optics)
Manufacturing under FDA compliant quality system
Class 10k Clean room, Class 100 clean bench Microscopy, fluorescence and imaging capability Fluidic test platform for engineering development Surface modification capability Component bonding using medical grade UV curing Pressure and Thermal bonding CO2 lasers with special focusing optics 3000 sq ft facility in Los Angeles County
Facilities
Core Competencies
Microfluidic, Lab-on-Chip Design & Fabrication Bioanalytical & Interfacial Science Materials and Membrane Science Instrumentation Development Manufacture under FDA Compliant Quality
System
Ideal for rapid prototyping, permits empirical testing hence lowers development costs, produces a better final product. Amenable to ‘mass customization” Robust, proven, inexpensive Incorporate different materials with little change in process. Create complexity without special tooling Simple interface to sensors or injection molded components “operational double sticky tape” Incorporation of functionality:valves,porous membranes, pumps Enclosed internal channels, high feature density
Polymer Laminate Technology
Well layer
Channel layer 2
Optical layer
Channel layer 1
Capping layer
Laminate Construction:NASA Cell Culture Card
Breathable membrane
Materials:
Optical Acrylic
Pressure sensitive adhesive
0.45 micron nylon membrane
Hose barb connector
Customer Base
Life Science Tools Developers Clinical Instrumentation Point of Care Diagnostics Environmental Test Labs Field Portable Instruments Life Science and Analytical Laboratories Government & Private Research Laboratories
How We Work with Clients
• Initial discussion of application and device requirements (may or may not require NDA).
• Client provides initial designs in pdf or dxf with part number and revision.
• ALine develops laminate fabrication process based on requirements, with design and documentation control.
• ALine sources materials and recommends bonding adhesive based on requirements.
• First set of prototypes fabricated on 6” x 12” footprint typical yield 6 to 12 devices.
• Typical turnaround time 3 to 7 days.• Testing of parts for function possible if specified in project
description.
General Design Rules
• No ceiling or floor of any channel is covered with adhesive.• Kerf is dependant on material thickness, range
approx. .002”(50 microns) to .005” (125 microns)• Feature size minimum, 100 microns in x-y plane in thin
material (75 microns or less)• Shortest channel height possible is 25 microns.• Feature density: require 0.5 mm spacing for 250 micron
thick channels. • Through holes or channel ends are oversized to
accommodate alignment shift.• Typical alignment 0.005”, 0.002” possible with additional
fixturing. • Connections: Tube stubs, o-rings, hose barb connections,
tapped threaded connections
Applications
Cell culture in space, fluidic card developed for NASA,
successful deployment and data collection in Dec. 2006
Multiplexed bacterial analysis of patient sample
PCR, molecular diagnostics
Flowcells for a variety of biomolecular analyses
Re-circulating pumps
Integrated electrodes for cell sorting
Specialty cuvettes for spectroscopy
Pneumatic valves for multiplexed applications
CD-sized Centrifugal Cartridge
Light weight polyethylene ester PET (Mylar) materials
75 wide x 50 micron tall channels
No adhesive on the top or bottom of wells or channels
Fluidic Manifolds
0.5 mm up to 2 mm thick close tolerance acrylic stacks,
Over 13 layers, 50 micron registration
Inexpensive alternative to diffusion bonding
Batch fabricate with stepped profile, does not need to be flat
500 micron to 1 mm wide channels
Cell for SAXS of protein solutions
Adhesive on top and bottom to permit placement of mica or other window material
Stack of three sheets of acrylic, 2.0 mm tall, 1.5 mm wide internal channel, 0.5” diameter
Notches permit use of tweezers to guide cell into a custom holder,
Cost about 1.50$ each
Each batch produced several hundred parts
Cell Sorting – Example of Electrochemical Interface
Laser Etched ITO on Glass or Au on Plastic, 25 micron tall fluid channel, side channel is 0.8 mm wide, main channel 2.5 mm, electrode gap is around 50 microns.
Glucose Sensing Flowcell
Pt electrode coated with GOX
Ag/AgCl reference
Electrodes threaded into the side of
the card, glued in place with UV cure
epoxy
On-Board Pneumatic Valves
Multiplexed analysis, split sample 4, 8 or 16 ways
Separate channels for independent reagent addition,
Bonded to injection molded reservoirs, Bacteria capture on coated glass slide, integrated into laminate assembly
Valves closed at 25 psi, for 5 psi fluid flow. Rule of thumb, closed at pneumatic pressure 5 x fluid pressure
Initial fill, closed valve still lets air pass, fill each channel to stop; create even flow among eight independent channels
Flowcells or Pipette Interface
Products for Spectroscopy Micro-volume Cuvettes: FluoroVette TM
SpecVette™ - Absorbance
Semi-micro to ultra-micro cuvette market
Available in 1.0, 0.5, and 0.25 mm pathlengths.
Cost effective alternative to expensive quartz cuvettes
Works in standard Spectrometer
Deliver Product with Superb Performance
Provide Cost Effective Solution to Custom Analytical Need
Permit Minimal Use of Precious & Costly Samples
Minimal Time Constraints Setting Up and Performing Tests
Meeting Customer Expectations
Contact information:
Dr. Leanna Levine
877-707-8575
www.alineinc.com
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